This invention relates to a method of predicting the risk of a non-osteoporotic human being contracting osteoporosis as a consequence of being in a long-term hormonally agonadal state and to a test kit for practicing this method.
Osteoporosis is a predictable sequalae in primates and other mammals to a long-term hormonally agonadal condition. Although it most frequently manifests itself in post-menopausal women in association with their longevity beyond the years of gonadal activity, it can occur in castrated males and females and in pre-menopausal women on long-term GnRH agonist or antagonist therapy, e.g., for the treatment of endometriosis or precocious puberty, or in instances of protracted amenorrhea due to extremes of exercise, anorexia or irradiation with or without chemotherapy affecting ovarian or testicular functions.
Few naturally occurring diseases adversely affect the quality and longevity of so many human lives as the sequelae to severe estrogen deficiency in the post-menopausal years. The prevalence of the disease is evident from the fact that about one woman in four will experience at least one bone fracture attributable to calcium depletion of the bone by the time she reaches the age of 60 years.
The benefits of estrogen replacement therapy (ERT) for conservation of bone calcium, prevention of hot flashes and amelioration of urogenital tissue atrophy in most postmenopausal and ovariectomized women are well known. Although most postmenopausal women gain obvious benefits from ERT, particularly when a family history, skeletal type, habits and genetic predisposition suggest that the individual is at significant risk, there are several reasons why mass ERT for all postmenopausal women is not medically acceptable to most practitioners. First, and perhaps most important, even though progestins are often overlapped sequentially with the estrogen in ERT, in order to shed proliferative endometrium and thereby reduce the risk of endometrial carcinoma, ERT regimens remain controversial with regard to incidences of endometrial carcinoma and cardiovascular complications. Second, women usually prefer to avoid menstruation beyond the natural menopause. However, some uterine bleeding is manifested by most of the women on current ERT/progestin regimens. Finally, a smaller but significant number of women do not require ERT in the postmenopausal years or can gain considerable symptomatic relief from progestins alone. Therefore, some diagnostic evaluation is employed by most physicians before instituting ERT; albeit highly subjective at this time.
Evaluations by bone densitometry for discrimination of those women most needing estrogens prophylactically can come too late to avert progressive osteoporosis, because such assessments are retrospective and the bone loss irreversible. Accordingly, a reliable predictive test to identify perimenopausal women who are highly vulnerable to the negative sequelae of severe estrogen deficiency would be useful to practitioners in deciding for whom, when and how to implement ERT, progestin treatment or a combination regimen.
Accordingly, it is an object of this invention to provide a method of obtaining from a non-osteoporotic human being an indicia which is reliably predictive of the magnitude of the risk of that patient ultimately contacting osteoporosis as a consequence of being in a long-term hormonally agonadal state.
Another object is to provide materials and specific reagents for kits for obtaining the aforesaid indicia.
Upon further study of the specification and appended claims, further objects and advantages of this invention will become apparent to those skilled in the art.